Knee OsteoarthritisNCT07134283
Effect of Preoperative Cold Therapy on Early Postoperative Outcomes in Total Knee Arthroplasty
A study testing Preoperative and Postoperative Cold Therapy with Gel Cold Pack and Postoperative Cold Therapy with Gel Cold Pack in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-center, randomized controlled trial investigates the effects of preoperative cold therapy on early postoperative outcomes in patients undergoing unilateral primary total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty, Cryotherapy
- What is being tested?
- Preoperative and Postoperative Cold Therapy with Gel Cold Pack and Postoperative Cold Therapy with Gel Cold Pack
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 55 years
- Diagnosed with advanced stage primary osteoarthritis of the knee
- Scheduled for unilateral primary total knee arthroplasty
- Provided written informed consent
Who cannot join
- Secondary osteoarthritis (e.g., post-traumatic, inflammatory arthritis)
- History of prior surgery on the affected knee
- Known hypersensitivity or intolerance to cold
- Comorbidities contraindicating cold therapy (e.g., diabetes mellitus, cold urticaria, peripheral vascular disease)
- Bleeding diathesis or on anticoagulant therapy
- History of severe hypertension or cardiovascular disease
Show all 9Show fewer
- Active neurological or psychiatric disorder
- Allergy to medications used in the study protocol
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperatively Initiated Cold Application on Postoperative Bleeding, Pain, and Functional Status in Total Knee Arthroplasty
This prospective, single-center, randomized controlled trial investigates the effects of preoperative cold therapy on early postoperative outcomes in patients undergoing unilateral primary total knee arthroplasty (TKA). A total of 208 patients were randomized into two groups: one receiving conventional cold therapy preoperatively and postoperatively, and the other receiving only routine postoperative cold therapy. Primary outcomes included postoperative pain (VAS), edema (thigh circumference), hemoglobin levels, drainage volume, opioid usage, Knee Society Scores (KSS), and presence of ecchymosis. The study demonstrated that initiating cold therapy before surgery significantly reduced postoperative drainage and opioid requirement, and delayed early edema progression. These findings suggest that the timing of cold therapy may influence recovery, highlighting a potentially beneficial approach to perioperative care in TKA.
Read the detailed description
This prospective, single-center, randomized controlled study aims to evaluate the early postoperative effects of initiating cold therapy in the preoperative period in patients undergoing total knee arthroplasty (TKA). While cold therapy is routinely applied in the postoperative period to reduce pain, swelling, and inflammation, limited evidence exists regarding the impact of starting cold therapy before surgery. In this study, a total of 208 patients diagnosed with advanced degenerative knee osteoarthritis and scheduled for unilateral primary cemented TKA were randomly assigned to two groups: one receiving conventional gel-based cold therapy both preoperatively and postoperatively (intervention group), and one receiving only standard postoperative cold therapy (control group).
Cold therapy was applied using gel packs at -17°C for 20 minutes with 40-minute intervals. The intervention group received three preoperative sessions prior to surgery and continued postoperatively for 48 hours. The control group received only the postoperative protocol.
The primary outcomes were postoperative pain (measured using Visual Analog Scale - VAS), edema (thigh circumference), hemoglobin levels, drainage output at 24 hours, and opioid consumption during the first 48 hours. Secondary outcomes included Knee Society Scores (KSS), hospital stay duration, and presence of ecchymosis.
The results demonstrated that preoperative initiation of cold therapy significantly reduced postoperative drainage volume and opioid consumption, and showed a trend toward slower edema progression and lower pain scores in the early postoperative period. This study proposes a novel approach in perioperative management by emphasizing the importance of cold therapy timing, and provides evidence that beginning therapy preoperatively may enhance recovery outcomes after TKA.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty, Cryotherapy, Postoperative Pain Management, Opioid Consumption, Postoperative
- Being tested
- Preoperative and Postoperative Cold Therapy with Gel Cold Pack, Postoperative Cold Therapy with Gel Cold Pack
- Keywords
- Total Knee Arthroplasty, Preoperative Cold Therapy, Cryotherapy, Postoperative Pain, Opioid Consumption, Knee Surgery, Drainage Output
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative and Postoperative Cold Therapy with Gel Cold PackProcedure or surgery
Also called Traditional CryotherapY, Cold Application, Conventional Gel Pack
Cold therapy was applied using a conventional gel cold pack , pre-cooled at -17°C for at least 2 hours. In the intervention group, cold application was performed three times before surgery (20 minutes per session with 40-minute intervals), and continued postoperatively for 24 hours with the same frequency. This protocol aimed to reduce pain, swelling, bleeding, and improve functional outcomes after total knee arthroplasty.
Postoperative Cold Therapy with Gel Cold PackProcedure or surgery
Also called Traditional Cryotherapy, Cold Application, Conventional Gel Pack
Cold therapy applied only in the postoperative period, for 24 hours, using the same method as the intervention group (20-minute applications with 40-minute breaks.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative and Postoperative Cold Therapy | Experimental | Patients in this group received conventional cold therapy (gel pack at -17°C) both before and after surgery. Three sessions were applied preoperatively (20 minutes with 40-minute intervals), and postoperative therapy was performed identically to the control group (20 minutes on / 40 minutes off for 24 hours). Receives: Procedure: Preoperative and Postoperative Cold Therapy with Gel Cold Pack |
| Postoperative Cold Therapy Only | Active comparator | Patients in this group received conventional cold therapy (gel pack at -17°C) after surgery only. Cold packs were applied to the knee region for 20 minutes with 40-minute intervals over a 24-hour postoperative period. Receives: Procedure: Postoperative Cold Therapy with Gel Cold Pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Scores for Pain
Pain intensity was assessed using the Visual Analog Scale (VAS) at rest at four time points: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Scale Range: 0 (no pain) - 10 (worst imaginable pain)
Directionality: Higher scores indicate worse pain
Measured: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Postoperative Drainage Volume
Total amount of fluid collected in the Hemovac drainage system during the first 24 hours after total knee arthroplasty (TKA). This measure is used as an indicator of postoperative bleeding and local inflammation, comparing the effect of preoperative cold therapy.
Measured: First 24 hours after surgery
Total Opioid Consumption in the First 48 Hours
Total opioid usage calculated as oral morphine equivalent in the first 48 hours after TKA. This includes all administered analgesics converted into oral morphine equivalent doses to evaluate pain control efficacy between study groups.
Measured: First 48 hours after surgery
Hemoglobin Level Change
Hemoglobin levels were recorded at four time points to evaluate perioperative blood loss: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Measured: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Knee Society Score (KSS)
Functional outcomes were measured using the KSS scale, which includes pain, range of motion, and stability. Scores were compared preoperatively and at 48 hours postoperatively.
Each component is scored from 0 to 100, with higher scores indicating better outcomes.
Measured: Preoperative and 48 Hours Postoperative
Thigh Circumference Measurement
Thigh circumference was measured 1 cm proximal to the superior patella border with the knee in full extension, to assess postoperative swelling. Measurements were taken preoperatively, 24 hours postoperatively, and 48 hours postoperatively.
Measured: Preoperative, 24 Hours Postoperative, 48 Hours Postoperative
Secondary outcomes (3)
Presence of Ecchymosis
Ecchymosis was visually evaluated and recorded at 24 hours postoperatively and 48 hours postoperatively in both groups.
Measured: 24 Hours Postoperative and 48 Hours Postoperative
Need for Blood Transfusion
The number of patients who required postoperative blood transfusion was recorded and compared between the groups. The transfusion threshold was hemoglobin <8 g/dL in hemodynamically stable patients. The outcome will be assessed throughout the hospitalization period after surgery.
Measured: From Surgery Until Hospital Discharge(2 to 7 Days Postoperative)
Length of Hospital Stay
The duration of hospitalization in days was recorded for each patient, from the day of surgery until discharge.
Measured: Through Hospital Discharge (Estimated 2 to 7 Days Postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start10 Jun 2024
- Primary completion30 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized 1:1 into two parallel groups to receive either preoperative and postoperative cold therapy or only postoperative cold therapy.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Faruk Naldoven, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134283
- Sponsor's protocol ID
- TABED 1-24-331
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pieri L, Leggieri F, Bartoli D, Ponti M, Caparrini C, Baldini A. Preoperative knee joint hypothermia reduces inflammation and recovery time and increases range of motion after total knee arthroplasty: A randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2025 Dec;33(12):4312-4323. doi: 10.1002/ksa.12756. Epub 2025 Jul 2.
PubMed 40601965Chareancholvanich K, Keesukpunt W, Pornrattanamaneewong C, Narkbunnam R, Jarusriwanna A. Comparison of three cryotherapy techniques for early post-TKA pain control in terms of efficacy and patient satisfaction: a randomized controlled trial. Arthroplasty. 2025 Jan 8;7(1):5. doi: 10.1186/s42836-024-00287-7.
PubMed 39773549Thienpont E. Does advanced cryotherapy reduce pain and narcotic consumption after knee arthroplasty? Clin Orthop Relat Res. 2014 Nov;472(11):3417-23. doi: 10.1007/s11999-014-3810-8. Epub 2014 Jul 25.
PubMed 25059851Hawker G, Wright J, Coyte P, Paul J, Dittus R, Croxford R, Katz B, Bombardier C, Heck D, Freund D. Health-related quality of life after knee replacement. J Bone Joint Surg Am. 1998 Feb;80(2):163-73. doi: 10.2106/00004623-199802000-00003.
PubMed 9486722
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperatively Initiated Cold Application on Postoperative Bleeding, Pain, and Functional Status in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07134283
- Acronym / sponsor ID
- TABED 1-24-331
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty, Cryotherapy, Postoperative Pain Management, Opioid Consumption, Postoperative
- Keywords
- Total Knee Arthroplasty, Preoperative Cold Therapy, Cryotherapy, Postoperative Pain, Opioid Consumption, Knee Surgery, Drainage Output
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, single-center, randomized controlled trial investigates the effects of preoperative cold therapy on early postoperative outcomes in patients undergoing unilateral primary total knee arthroplasty (TKA). A total of 208 patients were randomized into two groups: one receiving conventional cold therapy preoperatively and postoperatively, and the other receiving only routine postoperative cold therapy. Primary outcomes included postoperative pain (VAS), edema (thigh circumference), hemoglobin levels, drainage volume, opioid usage, Knee Society Scores (KSS), and presence of ecchymosis. The study demonstrated that initiating cold therapy before surgery significantly reduced postoperative drainage and opioid requirement, and delayed early edema progression. These findings suggest that the timing of cold therapy may influence recovery, highlighting a potentially beneficial approach to perioperative care in TKA.
Detailed description
This prospective, single-center, randomized controlled study aims to evaluate the early postoperative effects of initiating cold therapy in the preoperative period in patients undergoing total knee arthroplasty (TKA). While cold therapy is routinely applied in the postoperative period to reduce pain, swelling, and inflammation, limited evidence exists regarding the impact of starting cold therapy before surgery. In this study, a total of 208 patients diagnosed with advanced degenerative knee osteoarthritis and scheduled for unilateral primary cemented TKA were randomly assigned to two groups: one receiving conventional gel-based cold therapy both preoperatively and postoperatively (intervention group), and one receiving only standard postoperative cold therapy (control group).
Cold therapy was applied using gel packs at -17°C for 20 minutes with 40-minute intervals. The intervention group received three preoperative sessions prior to surgery and continued postoperatively for 48 hours. The control group received only the postoperative protocol.
The primary outcomes were postoperative pain (measured using Visual Analog Scale - VAS), edema (thigh circumference), hemoglobin levels, drainage output at 24 hours, and opioid consumption during the first 48 hours. Secondary outcomes included Knee Society Scores (KSS), hospital stay duration, and presence of ecchymosis.
The results demonstrated that preoperative initiation of cold therapy significantly reduced postoperative drainage volume and opioid consumption, and showed a trend toward slower edema progression and lower pain scores in the early postoperative period. This study proposes a novel approach in perioperative management by emphasizing the importance of cold therapy timing, and provides evidence that beginning therapy preoperatively may enhance recovery outcomes after TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Participants were randomized 1:1 into two parallel groups to receive either preoperative and postoperative cold therapy or only postoperative cold therapy.
| Arm | Type | Receives |
|---|---|---|
| Preoperative and Postoperative Cold Therapy | Experimental | Procedure: Preoperative and Postoperative Cold Therapy with Gel Cold PackPatients in this group received conventional cold therapy (gel pack at -17°C) both before and after surgery. Three sessions were applied preoperatively (20 minutes with 40-minute intervals), and postoperative therapy was performed identically to the control group (20 minutes on / 40 minutes off for 24 hours). |
| Postoperative Cold Therapy Only | Active comparator | Procedure: Postoperative Cold Therapy with Gel Cold PackPatients in this group received conventional cold therapy (gel pack at -17°C) after surgery only. Cold packs were applied to the knee region for 20 minutes with 40-minute intervals over a 24-hour postoperative period. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 55 years
- Diagnosed with advanced stage primary osteoarthritis of the knee
- Scheduled for unilateral primary total knee arthroplasty
- Provided written informed consent
Key exclusion criteria (9 listed)
- Secondary osteoarthritis (e.g., post-traumatic, inflammatory arthritis)
- History of prior surgery on the affected knee
- Known hypersensitivity or intolerance to cold
- Comorbidities contraindicating cold therapy (e.g., diabetes mellitus, cold urticaria, peripheral vascular disease)
- Bleeding diathesis or on anticoagulant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative and Postoperative Cold Therapy with Gel Cold PackAlso: Traditional CryotherapY, Cold Application, Conventional Gel PackCold therapy was applied using a conventional gel cold pack , pre-cooled at -17°C for at least 2 hours. In the intervention group, cold application was performed three times before surgery (20 minutes per session with 40-minute intervals), and continued postoperatively for 24 hours with the same frequency. This protocol aimed to reduce pain, swelling, bleeding, and improve functional outcomes after total knee arthroplasty. | Procedure or surgery | Preoperative and Postoperative Cold Therapy |
| Postoperative Cold Therapy with Gel Cold PackAlso: Traditional Cryotherapy, Cold Application, Conventional Gel PackCold therapy applied only in the postoperative period, for 24 hours, using the same method as the intervention group (20-minute applications with 40-minute breaks. | Procedure or surgery | Postoperative Cold Therapy Only |
Primary outcome
Visual Analog Scale (VAS) Scores for Pain
Time frame: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Pain intensity was assessed using the Visual Analog Scale (VAS) at rest at four time points: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative Scale Range: 0 (no pain) - 10 (worst imaginable pain) Directionality: Higher scores indicate worse pain
Postoperative Drainage Volume
Time frame: First 24 hours after surgery
Total amount of fluid collected in the Hemovac drainage system during the first 24 hours after total knee arthroplasty (TKA). This measure is used as an indicator of postoperative bleeding and local inflammation, comparing the effect of preoperative cold therapy.
Total Opioid Consumption in the First 48 Hours
Time frame: First 48 hours after surgery
Total opioid usage calculated as oral morphine equivalent in the first 48 hours after TKA. This includes all administered analgesics converted into oral morphine equivalent doses to evaluate pain control efficacy between study groups.
Hemoglobin Level Change
Time frame: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Hemoglobin levels were recorded at four time points to evaluate perioperative blood loss: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Knee Society Score (KSS)
Time frame: Preoperative and 48 Hours Postoperative
Functional outcomes were measured using the KSS scale, which includes pain, range of motion, and stability. Scores were compared preoperatively and at 48 hours postoperatively. Each component is scored from 0 to 100, with higher scores indicating better outcomes.
Thigh Circumference Measurement
Time frame: Preoperative, 24 Hours Postoperative, 48 Hours Postoperative
Thigh circumference was measured 1 cm proximal to the superior patella border with the knee in full extension, to assess postoperative swelling. Measurements were taken preoperatively, 24 hours postoperatively, and 48 hours postoperatively.
3 secondary outcomes
Presence of Ecchymosis
Time frame: 24 Hours Postoperative and 48 Hours Postoperative
Need for Blood Transfusion
Time frame: From Surgery Until Hospital Discharge(2 to 7 Days Postoperative)
Length of Hospital Stay
Time frame: Through Hospital Discharge (Estimated 2 to 7 Days Postoperative)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Results publication: PubMed 40601965Pieri L, Leggieri F, Bartoli D, Ponti M, Caparrini C, Baldini A. Preoperative knee joint hypothermia reduces inflammation and recovery time and increases range of motion after total knee arthroplasty: A randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2025 Dec;33(12):4312-4323. doi: 10.1002/ksa.12756. Epub 2025 Jul 2.
- Results publication: PubMed 39773549Chareancholvanich K, Keesukpunt W, Pornrattanamaneewong C, Narkbunnam R, Jarusriwanna A. Comparison of three cryotherapy techniques for early post-TKA pain control in terms of efficacy and patient satisfaction: a randomized controlled trial. Arthroplasty. 2025 Jan 8;7(1):5. doi: 10.1186/s42836-024-00287-7.
- Results publication: PubMed 25059851Thienpont E. Does advanced cryotherapy reduce pain and narcotic consumption after knee arthroplasty? Clin Orthop Relat Res. 2014 Nov;472(11):3417-23. doi: 10.1007/s11999-014-3810-8. Epub 2014 Jul 25.
- Results publication: PubMed 9486722Hawker G, Wright J, Coyte P, Paul J, Dittus R, Croxford R, Katz B, Bombardier C, Heck D, Freund D. Health-related quality of life after knee replacement. J Bone Joint Surg Am. 1998 Feb;80(2):163-73. doi: 10.2106/00004623-199802000-00003.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative and Postoperative Cold Therapy with Gel Cold Pack and Postoperative Cold Therapy with Gel Cold Pack in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Scores for Pain (time frame: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07134283, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.